A
Hi folks:
We have a Class II device with a power supply which is external to the unit (i.e. just like a laptop battery charger).
My question is this: for 510(k) approval of the device (whether it be traditional, abbreviated or special), must we test to IEC 60601-1 and IEC 60601-1-2 or declare conformity with both of those standards?
Thanks!
We have a Class II device with a power supply which is external to the unit (i.e. just like a laptop battery charger).
My question is this: for 510(k) approval of the device (whether it be traditional, abbreviated or special), must we test to IEC 60601-1 and IEC 60601-1-2 or declare conformity with both of those standards?
Thanks!